Being cognizant of medications is important for patients and healthcare professionals alike. It is important to know what a medication is used for, common side effects to be aware of, how much a medication may cost, drug interactions that may occur, and so on.
In some circumstances, it is also important to be able to further identify a specific medication and where it is sourced from. This primarily relates to knowing the manufacturer and batch from which a medication was produced.
Medications, even amongst generic products that contain the same active ingredient, can vary by manufacturer, dosage form, strength, and/or inactive ingredients. There are a variety of situations where it may be important to be able to identify a medication other than simply knowing the medication name.
For one example, if a certain medication is recalled by the FDA or voluntarily by a manufacturer, it is important to know if a patient’s medicine is impacted by the recall. Recently, metformin ER 500 mg tablets were recalled by the FDA for NDMA impurities. However, at the time of the announcement on May 28th, 2020, the recall only applied to metformin ER products from the manufacturer Apotex Corp. If patients are taking metformin ER but do not know who the specific generic manufacturer is, it is important to be able to identify the metformin ER 500 mg tablet to see if it was produced by Apotex Corp or not.
A second example is identifying a medication found outside of the container it was originally packaged in. This applies to capsules and tablets more often than topical or liquid medications. This could happen if medications are taken out of vials and placed into pill boxes for weekly organization. It could also happen if medications are sorted into daily dose packs or in erroneous situations where pills are otherwise unorganized or scattered around. In these situations, it can be a common concern to be able to properly identify a medication based upon its physical appearance.
A third example relates to individuals that take multiple medications. Patients commonly are prescribed medicines from many prescribers and fill prescriptions at multiple pharmacies. As electronic medical records between different healthcare systems are usually not interconnected, it is commonplace for healthcare professionals not to be aware of every medicine that a patient is taking unless they are directly informed of it. Thus, it is a common need for patients (and caretakers) to be able to track what medicines a patient is comprehensively taking. This is accomplished by identifying each medicine by its appearance and/or pharmacy label. This comprehensive list can then be given to each healthcare provider at every respective health institution a person may be a patient of.
A fourth example relates to a situation where a patient complains of inactive ingredients contained within a certain medication for various possible reasons. By knowing the specific manufacturer of a medication, it is possible to look up its inactive ingredients, determine if there is an issue, and provide alternative products when needed.
When a patient or healthcare professional needs to identify a medication, the National Drug Code (NDC) and lot number are vital pieces of information to know. For tablets and capsules, it is also possible in many situations to identify the medication based upon the appearance and markings on the pill itself. These are discussed below.
National Drug Code (NDC)
Drug products are identified using a unique, three-part number called the National Drug Code (NDC). A medication’s NDC is its universal product identifier. The United States Food & Drug Administration (FDA) has a published list of comprehensive NDCs that is updated routinely.
A NDC consists of 9 to 11 digits and it has three different parts: a labeler code, a product code, and a package code.
The NDC can either be in 5-3-2 format or 5-4-1 format. The example in the image below is in the 5-3-2 format because the labeler code has 5 digits, the product code contains 3 digits, and the package code contains 2 digits. However, occasionally, the labeler code may only be 4 digits for codes that were assigned early on.
The labeler code is the portion of the code that identifies the manufacturer of a product. This portion of the code is assigned by the FDA. For example, all NDC’s for products made by Eli Lilly and Company have the labeler code 0002, Seattle Genetics products have the labeler code 51144, Sun Pharmaceutical Industries products have the labeler code 10631, and so on.
The product code identifies the specific product, inferrably. Using the example of the manufacturer Ascend Laboratories, two of their products are aripiprazole 2 mg (67877-430-38) and aripiprazole 5 mg (67877-431-01). Because both of these products are produced by the same manufacturer, Ascend Laboratories, they each have the same labeler code of 67877. However, because they are different strengths of aripiprazole, they have different product codes. So, the product code can designate the specific active ingredient and strength of the medicine.
The package code correlates to the specific package that the medicine was originally contained in. Using the example of the manufacturer Lupin Pharmaceuticals, one of their products is clomipramine 50 mg capsules. One stock bottle of clomipramine 50 mg capsules has a NDC of 68180-493-01 whereas another has a NDC of 68180-493-07. For the NDC that ends in 01, the stock bottle given to the pharmacy originally had 100 capsules contained inside of it. For the NDC that ends of 07, the stock bottle originally had 60 capsules contained inside of it. So, the package code designates the package type and/or package size.
The NDC is required to be on the original medication stock bottle after it is produced by a manufacturer. However, whenever a medicine is repackaged into a pharmacy vial, the NDC is not always listed. Some states and pharmacies require that the NDC appear on the pharmacy label, but this requirement is not uniform. If a pharmacy label does not describe the NDC, pharmacy personnel can typically inform a patient of the dispensed product’s NDC if desired.
Lot Number
A lot number can also be called a batch number, code number, or a lot code. However, these names all provide the same meaning.
A lot number specifies the particular batch of product produced by a manufacturer. Batch size varies from company to company. Knowing the lot number is mostly important for recall situations. Often, recalls announced by the FDA provide a specific batch (or batches) of certain medications, indicated by the lot number, that are affected by the recall.
The lot number on a medication bottle is commonly found next to the expiration date. For example, in the image below, the lot number is EA7CHF.
Similar to NDC’s, lot numbers are not always described on pharmacy labels. If the lot number of a dispensed medicine is needed, pharmacy personnel may be able to inform the patient of the corresponding lot number of the dispensed product.
Expiration Date
Like mentioned above, the expiration date is typically described alongside the lot number. However, unlike lot numbers, expiration dates (or beyond-use dates) are almost always described on all pharmacy labels and are required to be described on manufacturer stock bottles.
Although not helpful for identifying products themselves, expiration dates (or beyond-use dates) are crucial in helping to determine the safety and effectiveness of a medication. After the described expiration or beyond-use date, the safety and effectiveness of a medicine, as described on the FDA’s product labeling, can no longer be guaranteed.
FAST FACT: expiration dates are often printed on stock bottles in terms of a specific month and year. However, the exact day is not always described. When reading an expiration date, if the specific day is not listed, know that the last day of the corresponding month is the true expiration date. For example, if a medication has an expiration date of 07-2020, the medication’s expiration date would be 31 July 2020. Therefore, the medication would still be considered viable to take until the end of the day on 31 July 2020.
Pill Identifier
Whenever a tablet or capsule is found outside of its original container, it is a common need to be able to identify the pill for safety reasons.
Pills can be identified based on their shape, color, imprinted markings, and other miscellaneous characteristics.
To identify a pill, there are multiple online resources that can be used to identify a specific pill. Some freely accessible ones are:
Remember: these three, free described resources are not perfect. When in doubt, bring in the medicine at question to a pharmacist at a local pharmacy. Pharmacists have access to more robust pill identifier tools that are not available to common consumers.
All in all, it is important to be able to identify and source medications for numerous possible reasons – only a few possible instances are described above. By utilizing NDC’s, lot numbers, expiration dates, and pill identifier tools, it is possible to more precisely identify specific products.
References:
- National Drug Code Directory. United States Food & Drug Administration. Accessed 1 June 2020.
- FDA News Release – FDA Alerts Patients and Health Care Professionals to Nitrosamine Impurity Findings in Certain Metformin Extended-Release Products. United States Food & Drug Administration. Published 28 May 2020. Accessed 1 June 2020.
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